NMPA (CFDA) Updates

April 6, 2020

NMPA V.S FDA — Regulatory Response to the Coronavirus (COVID-19) Pandemic

China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (Covid-19) since late January. Two regulatory authorities share the same progress: Emergency approval channels have been […]
April 2, 2020

NMPA’s Multinational Expert Panel Meeting Going Virtual

The NMPA expert panel convening scientists, medical experts, government officials, manufacturer’s representatives and Clinical Research Organizations (CROs) from transcontinental locations is delivered online for the first time. The virtual conference […]
March 23, 2020

NMPA: More Access to Increase Patient Samples in Clinical Trial

NMPA and National Health Commission jointly issued the Administrative Measures of Medical Device Expanded Access for Clinical Trial on March 20, implementing from the date of publication. The draft version […]
March 19, 2020

Guideline on AI Imaging Software for Coronavirus: Four Keywords to Keep in Mind

NMPA published the Review Points of CT Image-Assisted Triage and Evaluation Software for Coronavirus (COVID-19)-Infected Pneumonia on March 5, 2020. The document provides guidance to AI software manufacturers on the […]
March 10, 2020

Big Step! NMPA Streamlines Registration Procedure for Imported Devices!

NMPA published the Draft Document of “Transfer Certificate of Approved Imported Device to Domestic Enterprise for Manufacturing” on March 5, 2020 for feedback. Feedbacks need to be submitted by March […]